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Top FDA Official to Speak at ISPE Meeting

The International Society for Pharmaceutical Engineering (ISPE) announced that the FDA’s deputy commissioner for medical products and tobacco, Stephen P. Spielberg, MD, PhD, will deliver a plenary address at the 2012 ISPE Annual Meeting, taking place November 11-14 in San Francisco.

Spielberg’s talk, “How the FDA is Advancing Regulatory Science through High Quality Collaboration,” will discuss how the FDA is addressing challenges and taking advantage of opportunities to advance regulatory science through collaborations with organizations like ISPE. The session will also feature an address by Murray Aitken, executive director, IMS Institute for Healthcare Informatics. Aitken’s speech, “Top Priorities and Trends for the Pharmaceutical Industry,” will deliver a global analysis of the industry supported by quantifiable data, as well as a forecast of top priorities and trends through 2016, including content that will be exclusive to ISPE’s Annual Meeting.

The plenary session is part of a four-day conference program designed to give pharmaceutical professionals a better understanding of the industry’s current technical and regulatory challenges and an opportunity to engage in open dialog to solve those challenges. Two special sessions will be of particular interest for those concerned with pharmaceutical quality, regulatory considerations or next steps for the industry:

* Executive Series: Distinguished industry leaders will participate in a strategic discussion of key areas identified by technical leaders as critical to the future of the pharmaceutical industry. Attendees will hear “Confessions of a Counterfeiter,” and other provocative discussion topics.

* International Regulatory Summit: High-level regulators from North America, Europe, Asia, and Latin America will discuss regional regulatory challenges and examine those challenges within the context of a global regulatory environment.

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading the scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, FL, its European office in Brussels, Belgium, an Asia Pacific office in Singapore, and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.